Endotracheal tube system and method of use

ABSTRACT

An improved endotracheal tube system and method of use is provided. The improved endotracheal tube system includes a standard endotracheal tube, an adapter with a first tube that may be positioned within an endotracheal tube and a second tube adapted for attachment to a bag-valve mask. The adapter has a CO 2  detector within it. The improved endotracheal tube system may also have a stylet positioned within the endotracheal tube and the adapter. The stylet may have a handle attached to it for easy removal from the adapter.

BACKGROUND OF THE INVENTION

The invention relates generally to the field of medical devices.Specifically, the invention relates to an endotracheal tube system thatprovides for proper placement of the endotracheal tube and forsubsequence carbon dioxide detection.

A serious problem in the resuscitation of patients is the fast andefficient insertion of an endotracheal tube into a patient and thendetermining whether the patient is respirating. A medical professionalresponding to a patient who is not breathing has very little time toreact because brain damage occurs after only four minutes without oxygenand brain death occurs at eight minutes without oxygen. Therefore, aneed exists to provide the medical professional with an improvedendotracheal tube system and method of use which quickly and efficientlyplaces the endotracheal tube within the patient and tests for properrespiration.

Capnography is the term generally associated with monitoringrespiration. Capnography specifically is the process of monitoring theconcentration of exhaled carbon dioxide in order to assess thephysiological status of patients receiving mechanical ventilation and todetermine the adequacy of ventilation. It is difficult for the medicalprofessional using a respirator to determine whether the patient isreceiving an adequate flow of oxygen without some form of capnography.The medical professional must observe whether the lungs are filling withair or whether the stomach is gurgling because it is filling with airbut without some form of capnography the medical professional is notassured whether the patient is receiving an adequate flow of oxygen. Forexample, the endotracheal tube may be inserted into the patient'sesophagus instead of the trachea. Therefore, a need has arisen for anefficient and economical way of determining whether the patient beingtreated with a resuscitator is actually receiving oxygen.

Carbon dioxide detectors are well known in the prior art for use with anendotracheal tube. However, the prior art carbon dioxide detectors areboth cumbersome and time consuming. Moreover, the prior art carbondioxide detectors are not integral with the endotracheal tubes andtherefore create problems when assembling prior to use upon a patient.Accordingly, an objective of the current invention is an improvedendotracheal tube system which incorporates a CO₂ detector directly toan endotracheal tube.

There have been attempts in the prior art to design a resuscitator thatintegrates a carbon dioxide detector. An example of such a device isdisclosed in U.S. Pat. No. 6,427,687 to Kirk. Unfortunately Kirk is bothtime consuming and cumbersome because it incorporates a carbon dioxidedetector into the resuscitator. Therefore, a medical professional usingKirk must incorporate a disposable CO₂ detector upon the regulator thusrequiring an additional step above merely inserting the endotrachealtube into the patient. A further example of a combination carbon dioxidedetector and resuscitator is disclosed in U.S. Pat. No. 6,584,974 toRatner. Ratner attaches the CO₂ detector directly to the resuscitatorand has the same disadvantages as the Kirk patent. Accordingly, it is anobjective of the prior art to incorporate the CO₂ detector in an adapterthat may be placed between the endotracheal tube and a bag valve mask.

An additional problem with the resuscitation of patients is thedifficulty in placing the endotracheal tube within the trachea. Thisdifficulty is overcome using a metal stylet placed within theendotracheal tube before insertion into the patient. The stylet providesrigidity to the endotracheal tube which provides the medicalprofessional control of the flexible plastic tubing of the endotrachealtube. The stylet is not reusable and must be disposed after every use.The stylet is necessary in emergency situations to assist inmanipulating an endotracheal tube through a tracheal tube that ispartially collapsed or blocked. The medical professional, because he orshe may not know of the problems associated with the trachea, must usethe stylet as a default for manipulating the endotracheal tube.Accordingly, an objective of the present invention is to incorporate astylet into the endotracheal tube system.

A still further objective of the present invention is to minimize theamount of pieces and assembly required by medical personnel. With everyadditional piece that is not preassembled creates increased search timefor the pieces, the possibility of dropping the pieces, and the concernfor inadequate attachment of multiple parts of the assembled system.Therefore, a further objective of the present invention is to create animproved endotracheal tube system which has all pieces preassembled intoa combination such that only a resuscitator or bag valve mask to beattached it.

A still further objective of the present invention is to minimize theamount of time for capnography and subsequent verification ofendotracheal tube placement within the trachea as opposed to theesophagus. It is of the utmost concern that no time is wasted forattaching and assembling pieces to the endotracheal tube that could havebeen preassembled and packaged.

In addition, it is a still further objective of the present invention toproduce an improved endotracheal tube system that is sold as a set asopposed to the individual pieces of an endotracheal tube, a CO₂ tubedetector, and a stylet. The set can be sold for a reduced price asopposed to the individual prices set for individual pieces.

These and other objectives of the present invention will become apparentfrom the following description of the invention.

SUMMARY OF THE INVENTION

The improved endotracheal tube system utilizes an adapter that is placedbetween an endotracheal tube and the bag-valve mask. The adapter has ahousing having a first tube for attachment to an endotracheal tube and asecond tube for attachment to a bag-valve mask. The adapter has a carbondioxide indicator within the housing that is in gaseous communicationwith the endotracheal tube but isolated from the outside atmosphere.

The improved endotracheal tube system has an endotracheal tube, anadapter having a housing containing a first tube attached to theendotracheal tube and a second tube for attachment to a bag-valve mask.The system also having a stylet placed within the endotracheal tube andthe adapter to provide temporary rigidity to the endotracheal tube. Theimproved endotracheal tube system may also have a carbon dioxideindicator within the adapter housing. Additionally, the system may havea handle attached to the stylet that facilitates removal of a styletfrom the endotracheal tube in the adapter but with handle having sealsupon it which prevent the outside atmosphere air interacting with thecarbon dioxide indicator.

In the method of the invention, an improved endotracheal tube system issupplied to the medical professional. The medical professional positionsan endotracheal tube of the system into a patient. The medicalprofessional will then remove the stylet from the endotracheal tube andthe adapter. The medical professional then places a bag-valve mask uponthe adapter and ventilates the patient. One ventilation cycleeffectively creates a color change in the carbon dioxide indicator ofthe system. If the carbon dioxide indicator changes color, theendotracheal tube is correctly placed within the trachea. If theendotracheal tube is not properly placed, no color change will beapparent, vomit or other stomach contents will enter the endotrachealtube, and the endotracheal tube must be discarded.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of the improved endotracheal tube system of thepresent invention.

FIG. 2 is an exploded view of the adapter with carbon dioxide detectorand a stylet having a handle attached to it.

FIG. 3 is a sectional view along line 3-3 of FIG. 2.

FIG. 3A is an alternate embodiment of the adapter having the carbondioxide detector held in tracks.

FIG. 4 is a picture of the prior art endotracheal tube system with abag-valve mask attached to it.

FIG. 4A is a front view of the adapter of FIG. 2.

FIG. 5 is the improved endotracheal tube system of the present inventionbeing inserted into a patient.

FIG. 6 is the improved endotracheal tube system of the present inventionwith the handle and stylet removed from the endotracheal tube.

FIG. 7 is the improved endotracheal tube system of the present inventionwith the bag-valve mask attached to the adapter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, the improved endotracheal tube system isgenerally designated by the reference numeral 10. The system has anadapter 12 that attaches to a standard endotracheal tube 14.

The endotracheal tube 14 has a distal end 16 that is positioned within apatient's trachea. The endotracheal tube 14 also has a proximal end 18in which the adapter 12 is placed. A standard endotracheal tube has aballoon 20 that is inflated once the endotracheal tube 14 is positionedin the patient. The balloon 20 prevents accidental withdrawal of theendotracheal tube from the trachea and specifically movement past thepatient's vocal chords. The balloon 20 is inflated by placing a syringe22 into the balloon inflating apparatus 24. The standard endotrachealtube may also have medication ports, suction ports, and other ports asdisclosed in the prior art.

The adapter 12 has a first tube 26 that fits into the proximal end 18 ofthe endotracheal tube 14. The first tube 26 may be tapered for insertioninto various sizes of endotracheal tube 18. The first tube may bevarious sizes depending upon the size of the endotracheal tube 18 used.Endotracheal tubes 18 may vary depending on the size and age of thepatient. The adapter has a second tube 28 for attachment to a bag-valvemask. The second tube 28 has an outer diameter that may range between 12millimeters (mm) to 20 mm and preferably has an outside diameter of 14mm with an inner diameter of 13 mm. The cylinder is preferably 16 mm to24 mm in length with a preferred length of 18 mm.

On the base of the second tube 28 are six holes equally spaced aroundthe circumference of the second tube 28. The holes 30 measureapproximately 3 mm in diameter. As seen in FIG. 3, a ring 32 with aC-shaped cross section defining a ring chamber 34 is adapted to beplaced over the second tube 28. Inside the ring chamber 34 is placed acarbon dioxide indicator 36. Litmus paper is chemically treatedtelemetric indicator paper that may be used to detect carbon dioxide.The carbon dioxide detector 36 goes into ring 32. The ring 32 may thenbe slid over the second tube 28 and positioned against flange 38. Thering 32 is then secured in place. The ring may be secured using adhesivebetween the interface of the ring 32 and second tube 28 and the ring 32and flange 38. As seen in FIG. 3A, the carbon dioxide detector may beheld in tracks 35 of the ring 34.

A stylet 40 is placed within the endotracheal tube 14 and the adapter12. A stylet provides rigidity to the endotracheal tube when beingplaced within a user's trachea. The stylet is attached to handle 42. Thehandle 42 has a plug 44 with seals 46 upon it. The plug 44 and seals 46create seal upon the adapter 12 so that air cannot come in contact withthe CO₂ detecting paper 36. FIG. 1 illustrates one seal 46 above theholes 30 and a second seal 46 below the holes 30. The position of theseals 46 is relevant because the distal end 16 of the endotracheal tube14 is not sealed.

As seen in FIG. 4, the prior art used a cumbersome CO₂ detector havingone end 104 that attaches to an endotracheal tube adapter 106. As seenin FIG. 4A, the endotracheal tube adapter 106 used in the prior art isof the same general size as the adapter 12 of the present invention butdoes not utilize any carbon dioxide indictor within the housing of theadapter, in gaseous communication with the endotracheal tube andisolated from the outside air or atmosphere. The CO₂ detector 102 in theprior art also has a second end 108 that is adapted to receive abag-valve mask 48.

The prior art as seen in FIG. 4 has four discreet pieces. The first twopieces being the endotracheal tube 14 with a standard adapter 106. Thesetwo pieces are typically supplied together and are sealed in a separatepackage. The third piece is the CO₂ adapter 102. The CO₂ adapter 102comes in a separate bag. The fourth piece is the stylet 110 which is aseparate piece removed from the endotracheal tube 14 and adapter 102before placing the CO₂ indicator 102 upon the adapter 102. The bag-valvemask 48 is reusable and therefore not considered as an additional piece.The following table illustrates the number of steps and times associatedwith using the prior art color CO₂ detector. TABLE 1 Prior art CO₂Detector Steps and Times STEP PROCEDURE SECONDS Step 1 Find endotrachealtube  5-10 Step 2 Open endotracheal tube bag and remove from bag 1-2Step 3 Find stylet  5-10 Step 4 Open stylet bag 1-2 Step 5 Insert thestylet into endotracheal tube  5-10 Step 6 Find CO₂ detector  5-10 Step7 Open CO₂ detector bag 1-2 Step 8 Utilize Larynengscope, find trachea,15-30 insert endotracheal tube Step 9 Fully inflate balloon 4-8 Step 10Remove stylet 1-2 Step 11 Attach CO₂ detector 1-2 Step 12 Attach bag toCO₂ detector 2-4 Step 13 Ventilate 10-15 Step 14 Check for color change1 Step 15 Remove bag from CO₂ detector 1-2 Step 16 Remove CO₂ detectorfrom endotracheal tube  5-15 Step 17 Replace ventilator ontoendotracheal 2-4 tube to ventilate

As seen in the above table, the best case scenario for emergency medicalpersonnel to insert an endotracheal tube into a person is 64 seconds.The worst case scenario takes much more time. A medical professional isunder an extreme amount of stress knowing that in four minutes a personwill encounter brain damage and that in eight minutes a person willencounter brain death. Therefore, the medical professional will beexperiencing both adrenaline and anxiety. In addition, the medicalprofessional may have problems and find the trachea obscured by thetongue or fatty deposits in the mouth. In addition, the worst casescenario may take much more time because the color change did notindicate that the endotracheal tube was in the larynx and then themedical professional must go back and repeat the steps beginning atStep 1. In addition, the medical professional may accidentally withdrawthe adapter 106 from the endotracheal tube 14 when removing the CO₂detector 102 and then the person will again have to repeat Step 1.

In summary, the best case scenario for the prior art method of detectingCO₂ may range between 64 to 126 second. The worst case scenario mayrange much longer than two minutes and creep dangerously close to thefour minute mark for brain damage and the eight minute mark for braindeath. Obviously, with the medical professional also having to encounterdelaying issues such as being transported to an accident site on thehighway every second matters.

The present invention as seen in FIGS. 5-7 reduce the amount of stepsand time. These reductions decreases the best case scenario time forinserting the endotracheal tube and limits the possibility for errorencountered. TABLE 2 The Present Invention's Steps for Inserting anEndotracheal Tube and Ventilating. STEP PROCEDURE SECONDS Step 1 Findendotracheal tube system  5-10 Step 2 Open endotracheal tube system bag1-2 Step 3 Insert Laryngoscope, find trachea, 15-30 insert endotrachealtube Step 4 Fully inflate balloon 4-8 Step 5 Remove stylet plug 1-2 Step6 Attach bag to adapter with CO₂ detector 2-4 Step 7 Ventilate 5 Step 8Check for Color Change 1

As seen in the above table, the best case scenario results in a processwhich takes between 34 to 62 seconds and reduces the amount of stepsfrom 17 to 8. In addition, the ventilation step is 5 seconds as opposedto 10-15 seconds because this design does not require a filter padbetween the litmus paper and the inner surface of the second tube 28because of the constantly sealed nature of the CO₂ detector using thehandle 42. The prior art requires 10-15 seconds because it may requiretwo to three ventilations of the bag as opposed to only one ventilationof the present invention. The present invention also has reduced timebecause it does not require needless opening of multiple bags but onlyone bag having the combination within it. The present invention also hasa reduced amount of time in a worse case scenario as the CO₂ detectorwill not be accidentally removed by having the bag valve removed toremove the CO₂ detector.

As a summary of FIGS. 5-7, the medical provider first inserts theimproved endotracheal tube system into a patient using a Laryngoscope50. As seen in FIG. 6, the medical provider then inflates the balloon 20using a syringe 22 attached to opening 24. The user can then withdrawthe handle 42 from the adapter 12 thus pulling the stylet 40 from theendotracheal tube in the adapter. As in FIG. 7, the user then attachesthe bag-valve mask or ventilator 48 and compresses the bag to press airinto the patient's lungs. The medical provider then permits thebag-valve mask to pull gas from the patient and if it is properly placedon the larynx, it will pull CO₂ rich gas from the user's lungs and passit through the CO₂ detector and the adapter 12. If there is no colorchange, the medical provider will remove the endotracheal tube 14 fromthe patient and replace with a fresh tube. If the endotracheal tube isin the larynx, the medical provider will continue to respirate thepatient.

The invention has been shown and described above with the preferredembodiments, and it is to be understood that many modifications,substitutions, and additions may be made which are within the intendedspirit and scope of the invention. From the foregoing, it can be seenthat the present invention accomplishes at least all of its statedobjectives.

1. An adapter to be placed between an endotracheal tube and bag-valvemask, the adapter comprising: a first tube for attachment to anendotracheal tube and a second tube for attachment to a bag-valve mask;a carbon dioxide indicator mounted on an exterior portion of the secondtube and being in gaseous communication with the endotracheal tube, andisolated from the atmosphere.
 2. The adapter of claim 1 wherein thefirst tube has a tapered insertion end for fitting within an end of theendotracheal tube.
 3. The adapter of claim 1 wherein the first andsecond tubes are axially aligned.
 4. The adaptor of claim 1 wherein thesecond tube has an orifice, and the carbon dioxide indicator covers theorifice, and further comprising a casing isolating the carbon dioxideindicator from the atmosphere. 5-6. (canceled)
 7. The adapter of claim 4wherein the carbon dioxide indicator surrounds the second tube over theorifice.
 8. The adapter of claim 1 wherein the carbon dioxide indicatoris a chemically treated colorimetric indicator paper.
 9. The adapter ofclaim 4 wherein the casing is a clear ring.
 10. The adapter of claim 9wherein the clear ring has a C-shaped cross section defining a channelfor receiving the carbon dioxide indicator.
 11. A combinationcomprising: an endotracheal tube; an adapter having a first tubeattached to the endotracheal tube and a second tube for attachment to abag-valve mask; a stylet placed within the endotracheal tube and theadapter to provide temporary rigidity to the endotracheal tube; a carbondioxide indicator on the adapter; and the endotracheal tube, adaptor,carbon dioxide indicator and stylet being pre-assembled and packaged asan assembly.
 12. The combination of claim 11 further comprising a handleattached to the stylet to facilitate removal of the stylet from theendotracheal tube and the adapter.
 13. The combination of claim 12wherein the handle interfaces with the second tube to form a seal. 14.(canceled)
 15. The combination of claim 14 further comprising an orificein the perimeter of the second tube, the carbon dioxide indicatorcovering the orifice, and further comprising a casing isolating thecarbon dioxide indicator from the atmosphere.
 16. (canceled)
 17. Amethod of placing an endotracheal tube within a patient and testing forplacement within the patient's trachea, the method comprising: providinga pre-assembled and packaged endotracheal tube, adapter attached to theendotracheal tube, carbon dioxide indicator, and stylet extendingthrough the endotracheal tube and the adapter; placing the pre-assembledendotracheal tube and stylet within the patient; removing the styletfrom the endotracheal tube and the adapter; placing a bag-valve maskupon the adapter; ventilating the patient; and determining properplacement of the endotracheal tube within the patient's trachea byobserving the carbon dioxide indicator.
 18. (canceled)
 19. The method ofclaim 17 further comprising: providing a handle attached to the styletand interfaced with the adapter to form an air-tight seal; gripping theendotracheal tube with one hand and pulling the handle to remove thestylet.
 20. The method of claim 17 further comprising the step engagingthe bag-valve mask for one ventilation cycle.